Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570772
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Study to Investigate Comparative Efficacy Safety and Immunogenicity Between AVT16 and Entyvio
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Parallel-Group Treatment Double-Blind 2-Arm to Investigate Comparative Efficacy Safety Immunogenicity Between Intravenous AVT16 and Entyvio in Male and Female Subjects 18 to 80 Years Inclusive Moderate to Severe Ulcerative Colitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study has been designed as a randomised parallel-group double-blind 2 arm study of the comparative efficacy safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active ulcerative colitis
Detailed Description:
The study will consist of a screening period a treatment and assessment period and an End of Study visit Eligibility for the study will be determined during a screening period Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None